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Completed

NCT Number: NCT01674491

Effects of Black Soy Peptide Supplementation on Blood Pressure

Black soy peptides have been shown to possess properties that may decrease blood pressure. To examine the effects of black soy peptides supplementation on blood pressure and oxidative stress in subjects with pre-hypertension or stage I hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomic

Seoul, 120-749, South Korea

About this study

Trial participants included men and women aged 30 to 65 years who had an average systolic blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits. Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3 pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received pouches containing casein that had a similar appearance to the black soy peptide tablet. During the intervention, we instructed study participants to continue their current food intake patterns and lifestyles so that total energy intake and energy expenditure would be constant during the course of trial. Participants brought back unconsumed pouches at their 4- and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we used this to assess the participants' adherence to their assigned intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Average systolic blood pressure (SBP) between 130 to 159 mmHg
  • Average diastolic blood pressure (DBP) between 80 to 99 mmHg, or both, based on an average of six measurements during two screening visits

Exclusion criteria

  • Previous diagnosed clinical hypertension
  • Self-reported use of anti-hypertensive medication
  • Abnormal liver or renal function
  • History of cardiovascular disease, cancer, thyroid or pituitary disease, or any other serious life-threatening illness that required regular medical treatment

Treatment and study plan

black soy peptide

Dietary Supplement

black soy peptide: 4.5g/day for 8 weeks

Primary outcomes

  1. change from baseline in Systolic blood pressure at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline in Diastolic blood pressure at 8 weeks

    Time frame: 8 weeks

  2. change from baseline in plasma malondialdehyde at 8 weeks

    Time frame: 8 weeks

  3. change from baseline in Urinary 8-epi-prostaglandin F2 at 8 weeks

    Time frame: 8 weeks

  4. change from baseline in Renin at 8 weeks

    Time frame: 8 weeks

  5. Change from baseline in angiotensin-converting enzyme at 8 weeks

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effects of Black Soy Peptide Supplementation on Blood Pressure and Oxidative Stress:A Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 28, 2012
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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